Adverse Event Clinical Research R4 Backport
1.0.1 - STU1 International flag

Adverse Event Clinical Research R4 Backport, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.1 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-ae-research-backport-ig/ and changes regularly. See the Directory of published versions

: adverse-event-device-death - XML Representation

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<AdverseEvent xmlns="http://hl7.org/fhir">
  <id value="adverse-event-device-death"/>
  <meta>
    <profile
             value="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/AdverseEvent-clinical-research"/>
  </meta>
  <text>
    <status value="extensions"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: AdverseEvent</b><a name="adverse-event-device-death"> </a><a name="hcadverse-event-device-death"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource AdverseEvent &quot;adverse-event-device-death&quot; </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-AdverseEvent-clinical-research.html">Adverse Event Clinical Research</a></p></div><p><b>Adverse Event Grade</b>: Grade 5 Death related to adverse event <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-v3-nciThesaurus.html">NCI Thesaurus</a>#C48275)</span></p><blockquote><p><b>Criteria reviewed in determining serious adverse event</b></p><blockquote><p><b>url</b></p><code>criterionCode</code></blockquote><p><b>value</b>: Results In Persistent Or Significant Disability <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-v3-nciThesaurus.html">NCI Thesaurus</a>#C11338)</span></p><blockquote><p><b>url</b></p><code>criterionPresent</code></blockquote><p><b>value</b>: false</p></blockquote><blockquote><p><b>Criteria reviewed in determining serious adverse event</b></p><blockquote><p><b>url</b></p><code>criterionCode</code></blockquote><p><b>value</b>: Requires Inpatient Hospitalization <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-v3-nciThesaurus.html">NCI Thesaurus</a>#C83052)</span></p><blockquote><p><b>url</b></p><code>criterionPresent</code></blockquote><p><b>value</b>: false</p></blockquote><blockquote><p><b>Criteria reviewed in determining serious adverse event</b></p><blockquote><p><b>url</b></p><code>criterionCode</code></blockquote><p><b>value</b>: Death Related to Adverse Event <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-v3-nciThesaurus.html">NCI Thesaurus</a>#C48275)</span></p><blockquote><p><b>url</b></p><code>criterionPresent</code></blockquote><p><b>value</b>: true</p></blockquote><blockquote><p><b>Criteria reviewed in determining serious adverse event</b></p><blockquote><p><b>url</b></p><code>criterionCode</code></blockquote><p><b>value</b>: Is Life Threatening <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-v3-nciThesaurus.html">NCI Thesaurus</a>#C84266)</span></p><blockquote><p><b>url</b></p><code>criterionPresent</code></blockquote><p><b>value</b>: false</p></blockquote><blockquote><p><b>Criteria reviewed in determining serious adverse event</b></p><blockquote><p><b>url</b></p><code>criterionCode</code></blockquote><p><b>value</b>: Congenital Anomaly or Birth Defect <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-v3-nciThesaurus.html">NCI Thesaurus</a>#C83117)</span></p><blockquote><p><b>url</b></p><code>criterionPresent</code></blockquote><p><b>value</b>: false</p></blockquote><blockquote><p><b>Criteria reviewed in determining serious adverse event</b></p><blockquote><p><b>url</b></p><code>criterionCode</code></blockquote><p><b>value</b>: Other Medically Important Condition <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-v3-nciThesaurus.html">NCI Thesaurus</a>#C82521)</span></p><blockquote><p><b>url</b></p><code>criterionPresent</code></blockquote><p><b>value</b>: false</p></blockquote><blockquote><p><b>Criteria reviewed in determining serious adverse event</b></p><blockquote><p><b>url</b></p><code>criterionCode</code></blockquote><p><b>value</b>: Required Intervention to Prevent Permanent Impairment/damage <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-v3-nciThesaurus.html">NCI Thesaurus</a>#C201939)</span></p><blockquote><p><b>url</b></p><code>criterionPresent</code></blockquote><p><b>value</b>: false</p></blockquote><p><b>Resulting Effect</b>: <span>: Condition with Deep puncture wound (disorder) - SNOMED CT code. Note this different than the AdverseEvent.code in this instance.</span></p><blockquote><p><b>Participant</b></p><blockquote><p><b>url</b></p><code>function</code></blockquote><p><b>value</b>: authenticator <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-v3-ParticipationType.html">ParticipationType</a>#AUTHEN)</span></p><blockquote><p><b>url</b></p><code>actor</code></blockquote><p><b>value</b>: <a href="Practitioner-practitioner-owen-oncologist.html">Practitioner/practitioner-owen-oncologist</a> &quot; ONCOLOGIST&quot;</p></blockquote><blockquote><p><b>Suspect Entity</b></p><blockquote><p><b>url</b></p><code>instance</code></blockquote><p><b>value</b>: <a href="Device-device-infuser.html">Device/device-infuser</a></p><blockquote><p><b>url</b></p><code>causality</code></blockquote></blockquote><blockquote><p><b>Suspect Entity</b></p><blockquote><p><b>url</b></p><code>instance</code></blockquote><p><b>value</b>: <a href="MedicationAdministration-medication-administration-kadcyla1.html">MedicationAdministration/medication-administration-kadcyla1</a></p><blockquote><p><b>url</b></p><code>causality</code></blockquote></blockquote><p><b>Expected In Research Study</b>: false</p><p><b>Note</b>: During infusion of kadcyla an infuser exploded, shrapnel from the explosion caused a fatal puncture wound.</p><blockquote><p><b>modifierExtension[http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/status]</b></p></blockquote><p><b>actuality</b>: actual</p><p><b>category</b>: Device <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-adverse-event-category.html">AdverseEventCategory</a>#device)</span></p><p><b>event</b>: Patient death due to device explosion <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="https://browser.ihtsdotools.org/">SNOMED CT</a>#370903006 &quot;Patient death or serious disability associated with the use or function of a device in patient care, in which the device is used or functions other than as intended (event)&quot;)</span></p><p><b>subject</b>: <a href="Patient-patient-example-kaitlyn-b1.html">Patient/patient-example-kaitlyn-b1</a> &quot; HAMMER&quot;</p><p><b>date</b>: 2020-05-20</p><p><b>seriousness</b>: Serious <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-adverse-event-seriousness.html">AdverseEventSeriousness</a>#serious)</span></p><p><b>outcome</b>: Fatal <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-v3-nciThesaurus.html">NCI Thesaurus</a>#C48275)</span></p><p><b>recorder</b>: <a href="Practitioner-practitioner-oncology-nurse-jane.html">Practitioner/practitioner-oncology-nurse-jane</a> &quot; NURSE&quot;</p><p><b>study</b>: <a href="ResearchStudy-clinical-trial-example-compass.html">ResearchStudy/clinical-trial-example-compass</a></p></div>
  </text>
  <extension
             url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/ae-grade">
    <valueCodeableConcept>
      <coding>
        <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
        <code value="C48275"/>
      </coding>
      <text value="Grade 5 Death related to adverse event"/>
    </valueCodeableConcept>
  </extension>
  <extension
             url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria">
    <extension url="criterionCode">
      <valueCodeableConcept>
        <coding>
          <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
          <code value="C11338"/>
          <display value="Results In Persistent Or Significant Disability"/>
        </coding>
      </valueCodeableConcept>
    </extension>
    <extension url="criterionPresent">
      <valueBoolean value="false"/>
    </extension>
  </extension>
  <extension
             url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria">
    <extension url="criterionCode">
      <valueCodeableConcept>
        <coding>
          <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
          <code value="C83052"/>
          <display value="Requires Inpatient Hospitalization"/>
        </coding>
      </valueCodeableConcept>
    </extension>
    <extension url="criterionPresent">
      <valueBoolean value="false"/>
    </extension>
  </extension>
  <extension
             url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria">
    <extension url="criterionCode">
      <valueCodeableConcept>
        <coding>
          <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
          <code value="C48275"/>
          <display value="Death Related to Adverse Event"/>
        </coding>
      </valueCodeableConcept>
    </extension>
    <extension url="criterionPresent">
      <valueBoolean value="true"/>
    </extension>
  </extension>
  <extension
             url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria">
    <extension url="criterionCode">
      <valueCodeableConcept>
        <coding>
          <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
          <code value="C84266"/>
          <display value="Is Life Threatening"/>
        </coding>
      </valueCodeableConcept>
    </extension>
    <extension url="criterionPresent">
      <valueBoolean value="false"/>
    </extension>
  </extension>
  <extension
             url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria">
    <extension url="criterionCode">
      <valueCodeableConcept>
        <coding>
          <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
          <code value="C83117"/>
          <display value="Congenital Anomaly or Birth Defect"/>
        </coding>
      </valueCodeableConcept>
    </extension>
    <extension url="criterionPresent">
      <valueBoolean value="false"/>
    </extension>
  </extension>
  <extension
             url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria">
    <extension url="criterionCode">
      <valueCodeableConcept>
        <coding>
          <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
          <code value="C82521"/>
          <display value="Other Medically Important Condition"/>
        </coding>
      </valueCodeableConcept>
    </extension>
    <extension url="criterionPresent">
      <valueBoolean value="false"/>
    </extension>
  </extension>
  <extension
             url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria">
    <extension url="criterionCode">
      <valueCodeableConcept>
        <coding>
          <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
          <code value="C201939"/>
          <display
                   value="Required Intervention to Prevent Permanent Impairment/damage"/>
        </coding>
      </valueCodeableConcept>
    </extension>
    <extension url="criterionPresent">
      <valueBoolean value="false"/>
    </extension>
  </extension>
  <extension
             url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/resultingEffect">
    <valueReference>
      <display
               value="Condition with Deep puncture wound (disorder) - SNOMED CT code. Note this different than the AdverseEvent.code in this instance."/>
    </valueReference>
  </extension>
  <extension
             url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/participant">
    <extension url="function">
      <valueCodeableConcept>
        <coding>
          <system
                  value="http://terminology.hl7.org/CodeSystem/v3-ParticipationType"/>
          <code value="AUTHEN"/>
        </coding>
      </valueCodeableConcept>
    </extension>
    <extension url="actor">
      <valueReference>🔗 
        <reference value="Practitioner/practitioner-owen-oncologist"/>
      </valueReference>
    </extension>
  </extension>
  <extension
             url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/suspect-entity">
    <extension url="instance">
      <valueReference>🔗 
        <reference value="Device/device-infuser"/>
      </valueReference>
    </extension>
    <extension url="causality">
      <extension url="entityRelatedness">
        <valueCodeableConcept>
          <coding>
            <system
                    value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
            <code value="C53260"/>
            <display value="Related"/>
          </coding>
        </valueCodeableConcept>
      </extension>
    </extension>
  </extension>
  <extension
             url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/suspect-entity">
    <extension url="instance">
      <valueReference>🔗 
        <reference
                   value="MedicationAdministration/medication-administration-kadcyla1"/>
      </valueReference>
    </extension>
    <extension url="causality">
      <extension url="entityRelatedness">
        <valueCodeableConcept>
          <coding>
            <system
                    value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
            <code value="C53256"/>
            <display value="Not Related"/>
          </coding>
        </valueCodeableConcept>
      </extension>
    </extension>
  </extension>
  <extension
             url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/expected-in-research-study">
    <valueBoolean value="false"/>
  </extension>
  <extension
             url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/note">
    <valueAnnotation>
      <text
            value="During infusion of kadcyla an infuser exploded, shrapnel from the explosion caused a fatal puncture wound."/>
    </valueAnnotation>
  </extension>
  <modifierExtension
                     url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/status">
    <valueCode value="completed"/>
  </modifierExtension>
  <actuality value="actual"/>
  <category>
    <coding>
      <system
              value="http://terminology.hl7.org/CodeSystem/adverse-event-category"/>
      <code value="device"/>
      <display value="Device"/>
    </coding>
  </category>
  <event>
    <coding>
      <system value="http://snomed.info/sct"/>
      <code value="370903006"/>
      <display
               value="Patient death or serious disability associated with the use or function of a device in patient care, in which the device is used or functions other than as intended (event)"/>
    </coding>
    <text value="Patient death due to device explosion"/>
  </event>
  <subject>🔗 
    <reference value="Patient/patient-example-kaitlyn-b1"/>
  </subject>
  <date value="2020-05-20"/>
  <seriousness>
    <coding>
      <system
              value="http://terminology.hl7.org/CodeSystem/adverse-event-seriousness"/>
      <code value="serious"/>
      <display value="Serious"/>
    </coding>
  </seriousness>
  <outcome>
    <coding>
      <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
      <code value="C48275"/>
    </coding>
    <text value="Fatal"/>
  </outcome>
  <recorder>🔗 
    <reference value="Practitioner/practitioner-oncology-nurse-jane"/>
  </recorder>
  <study>🔗 
    <reference value="ResearchStudy/clinical-trial-example-compass"/>
  </study>
</AdverseEvent>